A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
Inclusion Criteria:
- Female
- Any ethnic origin
- No contraindication of routine bilateral mammography
Exclusion Criteria:
- Any contraindications to mammographic screening, including but not limited to:
- Significant existing breast trauma
- Pregnancy
- Lactating
- Previous surgical biopsy
- Previous breast cancer
- Placement of an internal breast marker
- Breast implants
- Unable to understand and execute written informed consent
- Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single
exposure
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
To detect a statistically significant increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images. The ROC curves will be generated from the probability of malignancy scale, a score of 0% to 100%.
Outcome Time Frame:
Fall 2010
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
09-03
NCT ID:
NCT00971087
Start Date:
September 2009
Completion Date:
January 2013
Related Keywords:
- Breast Cancer
- Breast cancer
- breast cancer screening
- Breast Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Fletcher Allen Health Care | Burlington, Vermont 05401 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| University of Virginia | Charlottesville, Virginia 22908 |
| Elizabeth Wende Breast Clinic | Rochester, New York 14620 |
| Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
| Spectrum Health | Grand Rapids, Michigan 49503 |
| Boca Raton Community Hospital | Boca Raton, Florida 33486 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
| UC Davis | Sacramento, California 95817 |
| HOAG Memorial Hospital | Newport Beach, California 92658-6100 |
| Magee Women's Hospital | Pittsburgh, Pennsylvania 15213 |
| Scottsdale Medical Imaging Ltd. (SMIL) | Scottsdale, Arizona 85251 |
| Invision/Sally Jobe | Greenwood Village, Colorado 80111 |
| Memorial Florida | Hollywood, Florida 33021 |
| Luthern General - Advocate Health Care | Chicago, Illinois 60068 |
| Barnes Jewish | St. Louis, Missouri 63110 |
| York - Women's Imaging at Apple Hill | York, Pennsylvania 17403 |
| UTSW Center for Breast Care | Dallas, Texas 75039 |
| Memorial Hermann/ Memorial City | Houston, Texas 77074 |
| Intermountain Medical Imaging | Murray, Utah 84175 |
